Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma

Phase 2Not Yet RecruitingNCT07388836

Fujian Cancer Hospital198 enrolled

Overview

This is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin (GP) chemotherapy combined with toripalimab administered on different days (Day 1, Day 5, or Day 9) to compare treatment responses. The neoadjuvant phase includes 3 cycles of 21 days each, followed by concurrent chemoradiotherapy. The estimated enrollment period is from March 2026 to March 2028.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

198

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 70 years Histologically confirmed locoregionally advanced nasopharyngeal carcinoma (AJCC/UICC 8th edition stage II-III) At least one measurable target lesion per RECIST 1.1 ECOG performance status of 0-1 Estimated life expectancy ≥ 6 months Adequate hematologic, hepatic, renal, and coagulation function Negative pregnancy test for women of childbearing potential Willingness to use effective contraception during the study and for 12 months after treatment Signed informed consent Willing and able to comply with study procedures Not participating in any other interventional clinical trials during the study period Exclusion Criteria: * re first dose Active or suspected autoimmune disease requiring systemic treatment Ongoing systemic immunosuppressive therapy Active hepatitis B, hepatitis C, HIV infection, or other serious infections History of another malignancy within 5 years (except non-melanoma skin cancer or in situ cervical cancer) Pregnant or breastfeeding women Inability or unwillingness to use contraception as required Life expectancy \< 6 months

Outcomes

Primary Outcomes

Complete Response Rate

The proportion of participants achieving complete response (CR) after 2 cycles of neoadjuvant chemotherapy combined with toripalimab, as assessed by RECIST or institutional imaging criteria.

Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)

Secondary Outcomes

Objective Response Rate

The proportion of participants achieving complete response (CR) or partial response (PR) after 2 cycles of neoadjuvant chemo-immunotherapy.

Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)

Disease Control Rate

The proportion of participants with CR, PR, or stable disease (SD) after 2 cycles of neoadjuvant chemo-immunotherapy.

Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)

EBV DNA Clearance Rate

The proportion of participants with undetectable plasma Epstein-Barr virus (EBV) DNA levels after 2 cycles of neoadjuvant chemo-immunotherapy.

Time frame: After 2 cycles of neoadjuvant therapy (21-28 days for each cycle)

Incidence of Grade ≥3 Treatment-Related Adverse Events

The frequency of treatment-related adverse events (AEs) of grade 3 or higher, according to CTCAE version 5.0.

Time frame: From first dose until 30 days after the end of neoadjuvant therapy

Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts